Evaluation of ART Restorations Using Two Different Bulk-Fill Restorative Materials in Primary Molars

NCT06771362 | Completed

• 1 other identifier: COMU-FD-PD-IASIMSEK-001
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical study is to evaluate the success of two different bulk-fill restorative materials applied to teeth restored with atraumatic treatment at 3, 6, and 12-month follow-ups. The research seeks to address the following questions: Which bulk-fill restorative material is more effective in terms of clinical success? How does the clinical success of bulk-fill restorations change over time (3, 6, and 12 months)? How do the two materials compare in terms of functional, aesthetic, and biological outcomes? To what extent does the cavity size of teeth with interproximal caries, restored using atraumatic treatment, influence treatment success? In this study, asymptomatic teeth with aproximal caries in children aged 4-9 will be repaired using atraumatic treatment and assessed based on the Modified USPHS (United States Public Health Service) and Revised FDI (World Dental Federation) criteria.

Conditions

Dentin Caries

Keywords

tooth demineralization; dental caries; Stomatognathic Diseases; Atraumatic Restorative Treatment

Outcome Measures

Primary Outcomes (9)

• Change form 3 months to 12 months regarding

  alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does

  3-month,6-month,12 month

• Change from 3 months to 12 months regarding "Marginal adaptation"

  alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin

  3-month,6-month,12 month

• Change from 3 months to 12 months regarding "Surface roughness"

  alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects

  3-month,6-month,12 month

• Change from 3 months to 12 months regarding "Marginal staining"

  alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin

  3-month,6-month,12 month

• Change from 3 months to 12 months regarding "Retention"

  alpha: intact bravo: chipped/loss of material charlie: complete loss of crown

  3-month,6-month,12 month

• Change from 3 months to 12 months regarding "Incisal wear"

  alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure

  3-month,6-month,12 month

• Functional properties according to revised FDI (World Dental Federation) criteria.

  Functional properties: F2: Marginal adaptation measured by visual examination, short air drying, 250 μm probe. F3:Proximal contact point measured by visual examination and 25/50/100 μm blades. F4: Form and contour measured by visual examination. F5: Occlusion and occlusal wear measured by visual examination and articulation paper. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).

  3-month,6-month,12 month

• Biological properties according to revised FDI criteria

  Biological properties: B1: Caries at restoration margin (CAR) measured by visual examination, short air drying, and 250 μm probe. B2: Dental hard tissue defects at restoration margin measured by visual examination. B3: Postoperative hypersensitivity reported by patient and pulp status tested with cold stimulus. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).

  3-month,6-month,12 month

• Aesthetic properties according to revised FDI criteria

  Aesthetic properties: A1: Surface luster and surface texture measured by visual examination and short air drying. A2: Marginal staining measured by visual examination and short air drying. A3: color match measured by visual examination. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).

  3-month,6-month,12 month

Study Arms (2)

STELA BULK-FILL RESTORATION

EXPERIMENTAL

Stella Bulk-Fill composite restoration after ART

Procedure: ART with Bulk-Fill composite

GLASS IONOMER (Control)

OTHER

RIVA Self-Cure HV glass ionomer restoration after ART

Procedure: ART with Glass Ionomer

Interventions

ART with Bulk-Fill composite PROCEDURE

Restoration using Bulk-fill flowable self-cured composite

STELA BULK-FILL RESTORATION

ART with Glass Ionomer PROCEDURE

Restoration Using High-Viscosity Glass Ionomer Cement

GLASS IONOMER (Control)

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients and parents of the patients who accept to participate and sign the informed consent.
• Children between the ages of 4-9
• Healthy children without a history of serious systemic conditions necessitating chronic use of medications.
• Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS II index: code 4,5,6) affecting primary molars.
• Absence of former history of spontaneous pain from the offending tooth/teeth.
• Patients with an appropriate level of cooperation to complete treatment under clinical conditions.
• Teeth are in a restorable condition. Natural exfoliation of primary teeth to be treated should not be expected within two years.

You may not qualify if:

• Patients and parents of the patients who does not accept to participate and sign the informed consent
• Patients with special health care needs or any medical conditions.
• Primary molar teeth with excessive crown damage that cannot be restored.
• Primary molar teeth in which bone loss exceeds 1/3 of the roots.
• Primary molar teeth that have previously undergone root canal treatment or pulpotomy treatment.
• Presence of internal/external and root resorption in primary teeth to be treated.
• Root fracture, ankylosis or mobility in the primary teeth to be treated.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Canakkale Onsekiz Mart University

Çanakkale, Kepez, 17100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth Demineralization; Dental Caries; Stomatognathic Diseases

Interventions

glass ionomer

Condition Hierarchy (Ancestors)

Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 13, 2025
• Study Start: January 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 20, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)